TIL Relation to pCR After Neoadjuvant Therapy in Breast C... | NCT05206396

Studies
TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

NCT05206396

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jul 24, 2023Actual

Enrollment

270Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

TIL assessment in pre-existing histopathological specimens

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2022Actual

Primary Completion Date

Mar 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Jan 21, 2022

First Submission Date that Met QC Criteria

Jan 24, 2022

First Posted Date

Jan 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2023

Last Update Posted Date

Jul 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Neoadjuvant systemic treatment for breast cancer (used in locally advanced and operable breast cancer) includes anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients.

The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).

Detailed Description

Neoadjuvant systemic treatment for breast cancer is used in locally advanced and operable breast cancer. Standard neoadjuvant systemic therapy regimens for breast cancer patients include anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIL in breast cancer patients who completed neoadjuvant therapy		Tumour infiltrating lymphocytes will be examined on pre-existing histopathologic samples. Data will be extracted from the files of the patients including: Demographic data, clinicopathologic data, pathologic complete response, and date of last follow up.	Diagnostic Test: TIL assessment in pre-existing histopathological specimens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TIL assessment in pre-existing histopathological specimens	Diagnostic Test	TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of TIL relation to pathologic complete response	TIL examined from pre-existing histopathological specimens and data of pathologic complete response will be collected from medical records	1 year

Secondary Outcomes

Measure	Description	Time Frame
1-year disease-free interval	1-year disease-free interval will be collected from data in medical records	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 years old or more
Histologically proven invasive breast cancer
All patients diagnosed with breast cancer except T1N0 and Metastatic breast cancer
Patients who completed their systemic neoadjuvant therapy

Exclusion Criteria:

Second malignancy
Patients who started but didn't complete neoadjuvant systemic therapy
Patients who didn't undergo surgery after neoadjuvant systemic therapy
Pregnant patients

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients aged 18 years old or more, diagnosed with breast cancer fulfilling the inclusion criteria with available histopathological sample and complete medical records will be enrolled

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Iman A Sharawy, MD	Contact	01068280224		emanelsharawy@med.asu.edu.eg
Ahmad Gab Allah, MD	Contact	01066882266

Overall Officials

Name	Affiliation	Role
Iman Sharawy, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Ain Shams University	Recruiting	Cairo		20	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

The results of the study will be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

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Browse Branches

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